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BIO helped convene a group of over 30 academics from 7 countries in Latin America for meetings during November 13th-14th, 2018 at the Universidad de San Andres in Buenos Aires, Argentina. During these two days, the academics engaged in lively discussion of how to organize a new group of academic leaders in biotechnology whose mission will be to support the growth of biotechnology by proactively working to help shape regulatory, legislative, research and commercial policy environment to develop a culture of biotech innovation and entrepreneurship. The academics have named their group ALI-BIO, Latin American Academic Leaders in Innovation and Biotechnology.

Dialogue focused on specific issues led by volunteer members of ALI-BIO academics that desire a leadership role and have expertise on certain key issues, such as regulatory and intellectual property matters. Attendees led a discussion about regulatory frameworks necessary to support biotech and challenges in the region to bring regulations up to recognized global standards. The organization also discussed technology transfer and entrepreneurship issues with thought leaders who shared their experiences and success stories and how they are working to create centers of innovation in their local communities and within their academic settings.

Other dialogue focused on discussing next steps and a workplan for 2019. The academics decided to organize themselves in four working groups: Regulatory Affairs; Intellectual Property; Entrepreneurship and Technology Transfer; and Communications. Leaders were elected to oversee these working groups and others volunteered to participate as task force members, lending their expertise to future discussions. The group of academics also discussed methods to increase membership and to further drive establishment of the movement. As part of their communication’s agenda, the group is exploring whether to develop a subject specific website and other social media campaign tools.

Members agreed it will be beneficial to convene at least two in-person meetings in 2019. Initial dates for a first meeting next year is in March or April with a second meeting on the margins of the BIO Latin America Conference in September. Given the expertise of the Brazilian academics and the desire to keep this as regional as possible, one meeting will be located in Brazil with another location to be decided soon by ALI-BIO leaders.

The creation of this initiative is an opportunity for our sector to partner with key stakeholders to help drive the adoption of policy initiatives and interventions supportive of an innovative ecosystem. There is a shared interest in academia in participating actively in shaping the external environment and supporting a culture of innovation in the region so that the researchers and their academic institutions can continue to innovate, grow, and develop their local and regional economies.

ISPOR Chile organized an international seminar focusing on “Health Reform, Access and Financing of Medicines” at the University of San Sebastian, on November 28th, 2018.

During this event, results from the study “Analysis of Access to Innovative Medicines in Chile compared to other OECD countries“, were presented by IQVIA at the request of FIFARMA and CIF. The study compared registration and timing of reimbursement for 247 innovative molecules in Chile vs. the same parameters for twenty-two (22) OECD member countries.

According to the results, only 5 out of the 117 molecules registered in Chile have been included under the Ricarte Soto Law or are part of the GES pathologies, which means that less than 6% of the molecules registered in Chile are included in any of the broad reimbursement mechanisms available in the country. This percentage is far from the 70% average rate shown for the other OECD member countries.

In order to highlight relevant information from the study, Daniella Rodríguez, Engagement Manager of IQVIA Colombia said: “If we look at the data analyzed, we notice that Chile has a very good average time of registration of innovative medicines, with an average of only 7 months, the fastest of the countries studied, but on the other hand, Chile shows the longest delays in including these medicines into the coverage and public financing systems”.

Chile ranks 18th, among countries included in the study, with over 18 months of delay between registration and reimbursement, which is very distant from the 13-month averaged by other members.

In addition, Jean-Jacques Duhart, Executive Vice President of CIF, added: “The results of the study show that Chilean patients have much lower financial coverage from public health insurance, and therefore less access to innovative medicines and treatments than patients from the other OECD countries. Even Mexico, which has a lower GDP per capita, offers patients health coverage 7 times higher than Chile”.

Sharing the innovative pharmaceutical industry’s perspective, Luis Villalba, Executive Director of FIFARMA, indicated that: “Being able to develop and understand the data of a study as relevant as the one we present today, allows us to measure the importance of universal access to health. At FIFARMA we support all regional initiatives which promote innovation, access to health and patients´ education to achieve a comprehensive and transparent health system “.

The Ibero-American Alliance of Rare Diseases (ALIBER) celebrated its VI Meeting in the city of Bogota, Colombia, from November 20th to 22nd.

The VI ALIBER Meeting, a space for academia and updates, aimed at raising awareness about the importance of rare diseases in Ibero-America. The meeting was attended by leading specialists within the healthcare industry including representatives of the scientific and governmental fields, patient networks, and pharmaceutical companies.

FIFARMA, one of the organizations present at the event, was represented by Juan Carlos Trujillo, Director of Operations and International Policy of the Federation. The executive participated in the panel called Evaluation of Technologies in Colombia, where he spoke about the participation of patient network organizations in the evaluation of health technologies:

“In patient-centered health policies, the participation of patient organizations in the evaluation of health technologies is of vital importance,” said the expert.

The Ibero-American Alliance for Rare Diseases (ALIBER) is a non-profit organization founded in 2013 by 11 patient organizations, which has consolidated as a coalition that integrates and empowers different associations of people affected by rare diseases in Latin America.

ALIBER represents a total of 42 million people affected by rare diseases through over 500 organizations brought together by its 47 partners in 13 countries.

FIFARMA, committed to improve people’s access to health and patient empowerment, joins the initiatives of the region that promote innovation, universal access to health and the training of patients towards a comprehensive and transparent health system.

The third module of the Latin American Patient Academy (LAPA) took place in the city of Sao Paulo, Brazil, on November 8th.

LAPA promotes training in advocacy and public health policies in patient groups all over the region, and has the prestigious collaboration of academic experts. The initiative has the support of FIFARMA and is a program designed by the Global Alliance for Patient Access (GafPA), the International Alliance of Patiens’ Organizations (IAPO), and the Latin Alliance.

Throughout 2018, LAPA offered Modules 1 and 2, accompanied by webinars and case studies. At the end of the year, the program was closed with Module 3, whose main topic was patient’s participation in the processes of Research and Development of new medicines.

The most outstanding speakers included the Brazilian Society of Professionals in Clinical Research’s President Dr. Greyce Lousana, the University of Sao Paulo’s Center for Research in Health Law Scientific Co-Director Dr. Fernando Aith, and Dr. Michelle Arguelles and Dr. Luther Clarck from MSD, among others.

The event, which was attended by several groups of patients from Latin America, concluded the one-year cycle of technical and academic learning aimed at promoting the development of patient networks in the region.

FIFARMA sponsored the 5th Symposium of the ISoP Latin America Chapter. The event was held in the School of Public Health, Sao Paulo University, Brazil, on 29th and 30th October 2018.

The objective of the meeting was to analyze the current scenario and future challenges of pharmacovigilance in Latin America. In addition, the symposium was attended by notable panelists from both scientific and governmental fields and by patient associations representatives.

Dr. Fernanda Simioni Gasparoto, from ANVISA’s Pharmacovigilance Unit, presented an update of the Risk Management Plan in Brazil. Then, the award-winning journalist Natalia Cuminale, from Veja Magazine, led the panel on pharmacovigilance from the patient’s point of view. The panel was comprised by Dr. Anthony Wong and Cristina Andrusaitis from CEATOX, Dr. Ricardo García from ClapBIO, Dr. Luis Alesso representing ISoP, and journalist Priscilla Torres, coordinator of patient associations GRUPAR / EncontrAR and author of the blog Artitre Reumatoide (Brazil).

Since 2009, the official year of its creation, the ISoP Latin America Chapter has had outstanding new members in the region: ANMAT, ANVISA, Society of Pharmacovigilance of Venezuela, Argentine Society of Pharmacovigilance and the University of Buenos Aires, among others.

The IX Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH) was held in El Salvador from October 24th-26th, 2018. The meeting, entitled “Contributions of regulatory harmonization in the achievement of health for all,” commemorated 20 years of the PANDRH Network (Pan American Network on Drug Regulatory Harmonization) and 40 years of the Alma-Ata Declaration of 1978. The Network is a joint initiative of the National Regulatory Authorities of the Region and the Pan American Health Organization (PAHO) to support the harmonization of pharmaceutical regulation in the Americas.

The meeting was organized by the National Drug Directorate of El Salvador, in coordination with PAHO, and was attended by more than 300 healthcare leaders from 35 countries in Latin America. Following previous conferences in Ottawa and Mexico, this year’s event continued the discussion on strengthening of regulatory systems in the region.

FIFARMA promotes and supports the work of the PANDRH Network. In fact, in December 2017, the Executive Committee of the PANDRH Network approved the first joint initiative between PANDRH, FIFARMA and Cuba’s National Regulatory Authority (CECMED), titled “Evaluation of the Requirements of the Pharmaceutical Product Certificate (PPC) for registration processes in the Region of the Americas, towards more timely access to medicines and more convergent regulatory approaches.”

“…Because at some point in life we are all patients, we must guarantee transparency in everything we do.”

Plenary Session 5: Improvement of regulatory capacities

Thomas Schreitmueller, Global Head Regulatory Policy at F. Hoffmann – La Roche AG, Switzerland, shared the industry perspective on strengthening the regulatory system in the region:

“..The increasing speed of scientific progress, our understanding on the underlying causalities of diseases and as a result the availability of innovative healthcare solutions make the need for strong and efficient regulatory systems more urgent than ever before”

Plenary Session 6: The use of information in regulatory convergence

Jaime Oliveira, Head Regulatory Policy and Intelligence at Bayer Latin America, provided an update on the PANDRH Project (evaluation of CPP requirements for the registration of medicines):

“…The CPP project has reached a steady pace and gained great visibility in the Region and also globally through the WHO. This is the result of the work of the project’s coordinators, CECMED/Cuba and FIFARMA, and also of the engagement of National Regulatory Authorities and industry’s trade associations in the region of the Americas. We expect important outcomes from this project and that it becomes a concrete example that regulators and industry can work together to reach convergent objectives”.

Plenary Session 7: Regulatory approaches based on risk in all regulatory functions

FIFARMA held its 2018 Annual Regional Meeting on May 23 and 24 in Washington DC (US).

Member companies and associations met with the objective of analyzing and reviewing the strategies and activities implemented during the previous year and to develop an action plan for the Federation for 2019.

The first day of the regional meeting began with a strategic planning session with Vice Presidents from across the region, followed by the presentation of FIFARMA’S organizational objectives by FIFARMA’s Director General Luis Villalba, and Director of Operations and International Policy Juan Carlos Trujillo. FIFARMA’s session was followed by several presentations by leading experts, including Carlos Gutierrez (Chair of the Albright Stonebridge Group and former US Secretary of Commerce, 2005-2009), who spoke about the challenges and opportunities of current public policies, as well as Catherine Mellor (Executive Director, Global Health Initiative, ‎U.S. Chamber of Commerce) on the role of private actors in regional politics, and Sydney Clark (Senior Vice President, IQVIA) on the dynamics of the Latin America pharmaceutical market and the impact of digital communications in the pharmaceutical industry. Industry priorities were reviewed over a working lunch, and the day concluded with a FIFARMA Executive Committee meeting and a presentation of LATAM IP trends by PhRMA’s Chris Moore.

On the morning of the second day of the meeting, local associations had the opportunity to discuss their activities and priorities with representatives from PhRMA, BIO and FIFARMA. FIFARMA’s regional communications strategy was presented by María Alejandra De Guzman (Communications Manager, FIFARMA) and Harold Hamana (Managing Partner, Knight + Pawn), and followed by an update on OECD from PhRMA’s Carl Meacham. FIFARMA working groups met in the afternoon to discuss key strategic themes.

In summary, the meeting was successful in bringing together pharmaceutical companies, industry organizations and local associations to promote collaboration and alignment among FIFARMA members to help finalize and activate the Federation’s 2019 strategic plan.

Last Tuesday, September 18th, the Economist held the “War On Cancer LATAM: Shared Struggles, Collective Success” conference in Bogotá, Colombia. The event was well attended by leaders of the pharmaceutical industry in Latin America, including pharmaceutical companies executives, public sector representatives (State and National Government officials) and patient organizations.

FIFARMA and AFIDRO were main sponsors of the event and actively participated in promoting the dialogue between the different actors. Both institutions had their own stand (booth) at the event, and Mr. Gustavo Morales, Executive President of Afidro, participated in a panel discussion on the importance of engaging finance ministries.

During his presentation, Morales noted: “In Colombia, we choose private companies to manage health, but with public restrictions, and we have not benefited from competition from the private sector.” He also added: “We must agree on health as a fundamental right in Colombia.”

In a similar light, Fernando Fon Mendez, Medical and Regulatory Affairs Director of AMIIF, a member association of FIFARMA, spoke about the importance of cross-sector engagement in Mexico: “Mexico has noticed that it is important to involve different actors, not only health actors, who allow the creation of an interdisciplinary network to improve the health system.”

During the meeting, the results of a major study on lung cancer in Latin America were also disseminated.

The study, called ‘Lung Cancer in Latin America: Time to Stop Looking Away,’ was developed by The Economist Intelligence Unit with the support of Roche Laboratories, and analyzed data from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Paraguay, Peru and Uruguay. Their findings indicate that lung cancer has resulted in more than 60,000 deaths each year in these countries, with an annual cost of over US$ 1,600 million.

During the War On Cancer Conference, we saw prominent panelists from the scientific world, pharmaceutical companies, the public sector and from patient organizations united under a common goal: to promote access to health and the possibility of better treatments made available to the entire population.

At the end of the event, Juan Carlos Trujillo, FIFARMA’s Director of Operations and International Policy, concluded: “We are proud to support this type of event where dialogue is facilitated and promoted between the different key players that shape the biopharmaceutical industry.” He added: “Gathering in spaces, such as War On Cancer, where scientific and social conversations converge with the regulatory frameworks of each country in the region, is important to facilitate decision-making and the design of public policies in the biopharmaceutical industry.”

The Latin American Patient Academy (LAPA) held its second session during the 3rdAnnual Latin American Summit for the Promotion of Biological and Biosimilar Policies of GAfPAfrom September 6-7 in Lima, Peru.

In line with the goals of the Summit,the objective of LAPA’s second session was to highlight the important role of patients and patient organizations in the Health Technology Assessment process.28 leaders from Latin American patient organizations received training in the evaluation of health technologies.

The meeting was guided and executed by representatives from the pharmaceutical industry in Latin America.

LAPA, an advocacy capacity building program, is a joint program of the Global Alliance for Patient Access (GAfPA), the International Association of Patient Organizations (IAPO), and Alianza Latina, with academic support from the Department of Adult Virtual Education of the Catholic University of Peru, and financial support from 13 FIFARMA member pharmaceutical companies.

FIFARMA Status Renewed as Non-State Actor in Official Relations with PAHO

The renewal was confirmed during the 162nd PAHO Executive Committee Session

Latin America, July 2018 – During the 162nd Session of the Executive Committee of the Pan American Health Organization (PAHO), the status of FIFARMA as a Non-State Actor in official relations with PAHO was renewed for a period of three years.

The declaration was formalized in the framework of resolution CE162.R9 dated June 21, 2018.

“We are very grateful to all the members of our Federation for their support during this process, and we are proud to continue working together with PAHO to promote policies that facilitate innovation and access to health in the region,” said Mr. Luis Villalba, FIFARMAGeneral Director.

“FIFARMA currently represents 13 pharmaceutical laboratories and 9 pharmaceutical associations in Latin America,” added FIFARMA Operations and International Policy Director Juan Carlos Trujillo. “We serve as a bridge between medical and patient associations, private actors such as pharmaceutical laboratories, and governments. Renewing our status as Non-State Actor in official relations with PAHO confirms our role and motivates us to continue working to drive innovation and access to health for the entire population of Latin America.”

About FIFARMA:

FIFARMA is the Latin American Federation of Pharmaceutical Industry, a regional organization created in 1962, which represents 13 Research and Development Pharmaceutical Companies and 9 local Trade Associations across the Latin American region. FIFARMA members are involved in the research and development of innovative healthcare products and provide state-of-the-art healthcare solutions through a variety of products and services aimed to improve and save patients’ lives across the globe, placing patient safety as one of its main objectives. www.fifarma.org